PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)

K023081 · Medical Bio Care Sweden AB · GEX · Dec 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023081
• Device Name: PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
• Applicant: Medical Bio Care Sweden AB
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProLite / Plasmalite MPX Pulsed Light System is indicated to permanently reduce unwanted hair.

Device Story

The ProLite / Plasmalite MPX Pulsed Light System is a powered surgical instrument used for hair removal. It delivers pulsed light starting at a wavelength of 600 nm to target melanin in human hair follicles via selective photothermolysis. The device consists of a cabinet housing an internal cooling system, power supply, and microcontroller, connected via an umbilical to a handpiece containing a waveguide. It is intended for use by healthcare professionals in dermatology or plastic surgery settings. The device output is controlled by the operator to achieve hair reduction, which is intended to benefit patients by providing a permanent reduction of unwanted hair.

Clinical Evidence

Clinical studies evaluated hair removal efficacy and safety. Observations were recorded pre-treatment and at 3-6 months post-treatment. Results indicated no scarring in any subject and confirmed that selective photothermolysis targeting melanin in the hair follicle is an effective tool for hair removal. Performance was compared to the predicate device.

Technological Characteristics

The device is a pulsed light system delivering light starting at 600 nm. It features a cabinet with an internal cooling system, power supply, and microcontroller, connected to a handpiece with a waveguide. It is a Class II device (Product Code GEX).

Indications for Use

Indicated for permanent reduction of unwanted hair in patients seeking hair removal.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• EpiLight / Photoderm HR System (K991935)

Submission Summary (Full Text)

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# DEC 1 6 2002

### Attachment I 510(K) Summary ProLite / Plasmalite MPX Pulsed Light System

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This 510(K) Summary of safety and effectiveness for the ProLite / Plasmalite Pulsed Light System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Medical Bio Care Nordic AB. |
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| Address: | Lona Knapes gata 5<br>421 32 Vastra Frolunda,<br>Sweden |
| Contact Person: | Morgan Gustafsson |
| Telephone / Fax | 46.31.709.30.70 - Phone<br>46.31.709.30.79 - Fax |
| Preparation Date: | September 11, 2002 |
| Device Trade Name: | ProLite / Plasmalite MPX Pulsed Light System |
| Common Name: | Pulsed Light for Photoepilation |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device: | EpiLight / Photoderm HR System<br>K number K991935 |
| Description of the ProLite / Plasmalite<br>MPX Pulsed Light System | The ProLite / PlasmaliteMPX Pulsed Light System delivers<br>pulsed light at a wavelength beginning at a wavelength of<br>600 nm. The device consists of three interconnected<br>sections: The cabinet which houses the internal cooling<br>system, power supply and microcontroller, the umbilical to<br>the handpiece, and the handpiece, which houses the<br>waveguide |
| Intended use of the ProLite / Plasmalite<br>MPX Pulsed Light System | The ProLite / Plasmalite MPX Pulsed Light System is<br>indicated to permanently reduce unwanted hair. |
| Performance Data: | Clinical studies were conducted to provide assurance that<br>difference in the specifications of the ProLite / Plasmalite<br>MPX Pulsed Light System and the predicate device for hair<br>removal did not result in different performance during use.<br>These results were previously reported to the FDA in 510(K)<br>010927 |
| Results of Clinical Study: | Observation in the clinical study were recorded prior to<br>treatment and at 3-6 months after treatment. There was no<br>scarring in any subject. |
| | The study demonstrated that selective photothermolysis<br>targeting melanin in the human hair follicle is an effective<br>tool for hair removal. |
| Conclusion: | The ProLite / Plasmalite MPX Pulsed Light System is<br>substantially equivalent to other existing pulsed light<br>systems in commercial distribution for permanent hair<br>reduction in Dermatology and Plastic Surgery. |

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### Attachment I 510(K) Summary ProLite / Plasmalite MPX Pulsed Light System

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Bio Care Sweden AB c/o Connie White Hoy 908 Stetson Street Woodland, California 95776

Re: K023081

Trade/Device Name: Plasmalite Pulsed Light System for Permanent Reduction of Unwanted Hair

Regulation Number: 878.4810 Regulation Name: Instrument, surgical, powered laser Regulatory Class: Class II Product Code: GEX Dated: September 12, 2002 Received: September 17, 2002

Dear Ms. Hoy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in

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Page 2 - Ms. Connie White Hoy

the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k)<br>Number: | Pending<br>While he world / 1 doll - 100 million and | FOR FOR FOR BOOK IS THE FOR LE FOR A BOOK OF A BOO<br>A Comments of Children College of Children | been annual and send and property and access and acreased and relieves and any and any and any and any and any and any and any and out of the | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Device Name: ProLite / Plasmalite MPX Pulsed Light System

Indications for Use:

The ProLite / Plasmalite MPX is intended to be used for the permanent reduction of unwanted hair.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (per 21 CFR 801.109)

OR

Over-the-Counter Use

Muriam C Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023081